2013 Temperature Mapping Project(s) Summary

During 2013, Performance Validation executed 22 projects that included a temperature mapping component of project work. These projects were completed with multiple clients, across both Pharmaceutical and Medical Device life science industries. Equipment used during these mapping studies included PV’s own inventory of Vaisala data loggers measuring temperature only, or temperature and humidity, or using the Kaye Validator 2000 for projects involving extreme cold or heat. Performance Validation maintains its temperature mapping equipment in a calibrated and validated state for use in the regulated life science industry. A summary of the types of equipment mapped during 2013 are identified below:

Cryogenic Storage or Controlled Rate Freezers:

Using the Kaye Validator 2000, PV completed a qualification of a liquid nitrogen controlled rate freezer for a cell bank laboratory, including studies to determine acceptable load quantities and patterns to meet freezing rate criteria for cell viability.

Sub-Freezers:

Using the Kaye Validator 2000, PV completed a -80 deg C sub-freezer qualification and a blast freezer qualification for a CMO.

USP Freezers:

Using Veriteq VL-2000 temperature loggers:
– Completed several walk-in and reach-in freezer qualifications for a small medical device company.
– Completed several reach-in freezer qualifications for a lab facility at a large pharmaceutical manufacturer.

USP Cold Storage Refrigerators or Chill Rooms:

Using Veriteq VL-2000 temperature loggers:
– Completed walk-in and reach-in refrigerator/chill room qualifications for a small medical device company.
– Completed several reach-in refrigerator qualifications for several lab facilities at a large pharmaceutical manufacturer.

USP Controlled Room Temperature, Water Baths, or Incubators/Stability Chambers:

Using Veriteq VL-2000 temperature and humidity data loggers:

-Completed a number of walk-in stability chamber qualifications and requalifications for a pharma contract manufacture.
– Completed a number of local and remote initial seasonal temperature mappings for third party drug storage and distribution warehouses or raw material storage areas within pharmaceutical manufacturing facilities and provided recommendations for permanent monitoring locations within those facilities.
– Completed a number of controlled area HVAC qualifications and requalifications for a large dry products pharmaceutical manufacturer to verify temperature and humidity requirements within critical manufacturing and storage areas.
– Completed several reach-in stability chamber requalifications for a lab facility at a large animal health manufacturing facility.
– Completed short term monitoring of temperature and humidity controlled areas during electrical and maintenance shutdowns while the permanent monitoring system was off-line at a large pharmaceutical manufacturer.

Using Veriteq VL-2000 temperature loggers, completed several reach-in incubator qualifications and requalifications for several lab facilities at a large pharmaceutical manufacturer.

Autoclaves, Sterilizers, Steam-in-place (SIP):

Using the Kaye Validator 2000, completed SIP verification of existing fermenters and other process tanks and a lab autoclave validation for dry goods, liquids, and trash loads for an animal vaccine manufacturer.

Using the Kaye Validator 2000 and EZ test self-contained biological indicators:
– Completed SIP verification of two new 50,000L fermenter tanks, including SIP verification of the associated water filters and air filters for a large animal health manufacturing facility.
– Completed SIP verification of a new fermenter bump tank for a large animal health manufacturing facility.
-Completed validations and revalidations of several different steam autoclave loads, including cycle development of a new liquid load, and SIP verification of a portable tank for a pharma contract manufacturer.

Depyrogenation Tunnels or Dry Heat Ovens:

Using the Kaye Validator 2000, completed an oven temperature mapping for a large peanut manufacturer, including verification of zone temperatures throughout the entire roasting line for several different product types and recipes.

2013 Temperature Mapping Summary:

In summary, Performance Validation supported a wide range of temperature mapping activities for a broad range of clients, small and large, pharma and non-pharma, in 2013.  In addition to the projects detailed above and as another available service, Performance Validation rented Veriteq data loggers and Kaye Validator 2000 equipment to several different clients for internal completion of mapping work throughout 2013.  PV has the experience, expertise, and equipment to support the temperature mapping needs of the regulated life science industry.

For more information please contact:
Neil Enlow
Principle Validation Engineer
Performance Validation, LLC
Cell (317)-341-2819